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Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00385593
First Posted: October 9, 2006
Last Update Posted: December 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).

Condition Intervention Phase
Asthma, Bronchial Drug: Symbicort (budesonide/formoterol) Turbuhaler Drug: Conventional treatment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-week, Randomised, Open-label, Parallel-group, Multicentre Study. Study SPAIN

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to First Severe Asthma Exacerbation [ Time Frame: Baseline up to 6 months ]
    Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.


Secondary Outcome Measures:
  • Total Number of Severe Exacerbations [ Time Frame: Baseline up to 6 months ]
    Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.

  • Mean Use of as Needed Medication [ Time Frame: Baseline up to 6 months ]
    Mean use of as needed medication during the treatment period

  • Use of Inhaled Steroids [ Time Frame: Baseline up to 6 months ]
    Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)

  • Change in the Asthma Control Questionnaire(ACQ) Score [ Time Frame: Daily 14 days prior to each of visit 2-4 ]
    The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)

  • Peak Expiratory Flow (PEF) [ Time Frame: 6 months (end of the study) ]
    Peak expiratory flow (PEF)


Enrollment: 654
Study Start Date: September 2006
Study Completion Date: October 2008
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
  • Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
  • Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA)
  • A history of suboptimal asthma control the month prior to enrolment as judged by the investigator
  • Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment

Exclusion Criteria:

  • Previous treatment with Symbicort Single Inhaler;
  • Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.
  • Known or suspected hypersensitivity to study therapy or excipients.
  • A history of smoking ≥ 10 pack years.
  • Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385593


  Show 52 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carlos Barcina, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00385593     History of Changes
Other Study ID Numbers: D5890L00010
2005-005974-64
SPAIN
First Submitted: October 6, 2006
First Posted: October 9, 2006
Results First Submitted: October 14, 2009
Results First Posted: November 17, 2009
Last Update Posted: December 16, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists